Kornimate/medical-research-clean huggingface dataset:
hope consortium trial to reduce pain and opioid use in hemodialysis

Conditions: End Stage Renal Disease; Chronic Pain; Opioid Dependence

Summary: hope is a randomized clinical trial that will evaluate approaches to reducing pain and opioid use among patients with chronic pain who are receiving maintenance hemodialysis for end-stage renal disease. the hypothesis is that pain coping skills training will be effective at reducing pain and opioid use, and that buprenorphine will be acceptable and tolerable as an approach to managing physical dependence on opioids in this patient population.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. undergoing in-center maintenance hemodialysis for ≥90 days 3. english- or spanish-speaking 4. chronic pain defined as a response of "most days" or "every day" to the following question: "in the past 3 months, how often have you had pain?" answer options: never, some days, most days, every day 5. current pain, enjoyment of life and general activity scale (peg) score ≥ 4 6. willing to provide informed consent 7. willing to allow research team to obtain opioid pharmacy refill data 8. willing to allow research team to contact and work with their opioid prescriber exclusion criteria: 1. current opioid use disorder 2. current use of heroin 3. current non-opioid substance use disorder with the exception of tobacco use disorder 4. current use of methadone, buprenorphine, or naltrexone for opioid use disorder 5. current receipt of hospice care 6. cognitive impairment that, in the judgement of the research team, precludes trial participation 7. active suicidal intent 8. unstable bipolar disorder, schizophrenia, post-traumatic stress disorder, or other psychotic disorder 9. life expectancy \< 6 months 10. expected to receive a kidney transplant, transfer to another dialysis facility, or transition to home dialysis within 6 months 11. current incarceration 12. any other condition that the investigator considers precludes participation in the clinical trial subgroup with current or recent opioid use during eligibility screening all potential participants will have opioid use ascertained using the timeline follow back approach. the trial will enroll at least 300 participants (among the 640 total study participants) with current or recent opioid use defined as patient-reported prescription opioid use during at least 3 of the past 6 months. the number of participants in the opioid use subgroup will be monitored throughout the trial enrollment period. if the rate of enrollment into the opioid use subgroup is lower than targeted, trial enrollment will be restricted to individuals meeting the opioid use criteria as long as necessary to ensure that the total enrollment target for the trial is not met without reaching the opioid use subgroup target.

Keywords: hemodialysis pain opioids pain coping skills
everolimus (rad001) therapy of giant cell astrocytoma in patients with tuberous sclerosis complex

Conditions: Tuberous Sclerosis; Subependymal Giant Cell Astrocytoma

Summary: the purpose of the study is to evaluate the safety and potential side effects of everolimus (an experimental drug) on a person with tuberous sclerosis complex who also has been diagnosed with a brain tumor (astrocytoma) the hypothesis is that the drug will cause the tumor size to decrease, and may have beneficial activity separate from effects on tumors in patients.

tuberous sclerosis complex (tsc)is a genetic disorder with a birth incidence of approximately one in six thousand. five to twenty percent of patients with tsc will develop astrocytoma, a slowly progressive tumor. they grow and cause damage to surrounding brain tissue, blockage of spinal fluid (hydrocephalus), blindness, trouble walking, seizures, and brain damage. if untreated, they can be fatal. standard treatment involves surgery to remove the tumor; however surgery may itself cause brain damage, bleeding, or infection, as well as other complications. studies have shown that everolimus suppresses the chemicals that cause tumors to grow in tuberous sclerosis, and may cause them to shrink. the primary objective of this study is to find out the effects of everolimus on astrocytomas in a six month trial in patients with tuberous sclerosis who have been diagnosed with an astrocytoma

Eligibility criteria:
inclusion criteria: * age three years and older * if female and of child bearing potential, documentation of negative pregnancy test prior to enrollment. in the extension phase, all females of child bearing potential will be required to take monthly home pregnancy tests and record results on a provided diary card. * clinically definite diagnosis of tuberous sclerosis (modified gomez criteria or positive genetic test) * presence of giant cell astrocytoma as defined by imaging characteristics and serial increase in size of lesion on 2 or more mri scans * adequate renal function (creatinine \< 1.5 mg/dl) exclusion criteria: * serious intercurrent medical illness or other uncontrolled medical disease which could compromise participation in the study * significant hematologic or hepatic abnormality * continuous requirement for supplemental oxygen * intercurrent infection at initiation of everolimus * embolization of angiomyolipoma within one month; any other recent surgery within 2 months of initiation of everolimus * pregnant or lactating women * use of an investigational drug within the last 30 days * must be adequately recovered from the acute toxicities of any prior therapy * clinical evidence of impending herniation or focal neurologic deficit related to the subject's astrocytoma * unwilling or unable to use highly effective contraception

Keywords: tuberous sclerosis complex (tsc) subendymal giant cell astrocytomas (sega's) mammalian target of rapamycin (mtor) everolimus (rad001) tuberous sclerosis with subependymal giant cell astrocytomas
twenty-six week extension trial of org 50081 (esmirtazapine) in outpatients with chronic primary insomnia (176003/p05721/mk-8265-007)

Conditions: Sleep Initiation and Maintenance Disorders; Mental Disorders; Dyssomnias; Sleep Disorders; Sleep Disorders, Intrinsic

Summary: this trial is a 26-week, open label extension trial to investigate safety and explore efficacy of esmertazapine in participants with insomnia who completed protocol 21106/p05701/mk-8265-002 (nct00631657).


Eligibility criteria:
inclusion criteria: * sign written informed consent * completed clinical trial 21106/p05701/mk-8265-002 exclusion criteria: * any (serious) adverse event, medical condition or required concomitant medication deemed relevant for exclusion in trial 21106/p05071/mk-8265-002 as judged by the investigator * were significantly non compliant with protocol criteria and procedures of trial 21106/p05701/mk-8265-002, as judged by the investigator * pregnancy
previously untreated advanced non-small cell lung cancer (nsclc)

Conditions: Untreated Advanced Non-Small Cell Lung Cancer

Summary: avastin is a novel antiangiogenic agent that has recently been shown to improve response rates and survival of patients with advanced nonsquamous non-small cell lung cancer when added to front-line carboplatin/paclitaxel chemotherapy, and is now being routinely incorporated into the treatment of these patients. alimta is a recently approved chemotherapeutic that has shown activity against non-small cell lung cancer when given alone and in combination with carboplatin, has a favorable toxicity profile andrequires only a brief (10 minute) infusion time. therefore we propose to study the combination of avasin, alimta, and carboplatin administered as front-line therapy to patients with advanced nonsquamous non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: i am 18 years of age or older. i have advanced non-small lung cancer. i have not had any major surgical procedures within 28 days prior to my starting treatment. i have high blood pressure that is controlled. i am not on heparin, coumadin or lovonox for treatment of medical conditions. i do not have serious wound healing problems. i have not received any previous treatment, except radiation therapy for my disease. exclusion criteria: -
luteal support in artificial vitrified/warmed cycles with low progesterone

Conditions: IVF; Embryo Loss; Luteal Phase Defect

Summary: the study aims to evaluate the effect of an increased dose of vaginal progesterone supplementation on the incidence of ongoing pregnancy for patients with a suboptimal serum progesterone level (defined as \< 10 mcg/l) on the day of blastocyst transfer.


Eligibility criteria:
inclusion criteria: * informed consent form (icf) dated and signed * age ≥ 18 and \< 43 years old * body mass index (bmi) ≥ 18.5 kg/m2 and \< 35 kg/m2 * less than 4 previous assisted reproductive technologies (art) cycles * current pregnancy wish * patients undergoing a single vitrified/warmed single transfer in an artificial prepared endometrium cycle (ivf or icsi) exclusion criteria: * simultaneous participation in another clinical study * previous participation in this study * known reasons for impaired implantation (specifically: presence of a hydrosalpinx; presence of a type i, ii or iii fibroid; asherman's syndrome; uterine malformations, intrauterine adhesions, ≥ grade 3 endometriosis according to the asrm classification, endometrial tuberculosis) * repeated miscarriages (\> 2 miscarriages) * untreated and uncontrolled thyroid dysfunction * tumors of the ovary, breast, uterus, pituitary or hypothalamus * abnormal vaginal bleeding without a known/diagnosed cause * ovarian cysts or enlarged ovaries * fibroid tumors of the uterus incompatible with pregnancy * malformations of the reproductive organs incompatible with pregnancy * previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin) * risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia * active smoking * ongoing pregnancy * use of carbamazepine, rifampicin or phenytoin * those unable to comprehend the investigational nature of the proposed study
the prolonged use of topiramate for preventing migraine headaches

Conditions: Migraine

Summary: the purpose of this study is to evaluate the safety and effectiveness (beyond 6 months) of individualized doses (100 to 200 milligrams) of topiramate for the prevention of migraine headaches over a period of 26 weeks.

previous studies have shown that topiramate is effective in preventing migraine headaches. this study will start with a 4-week baseline period in which no treatment is given, followed by a 26-week period in which each patient's dose is adjusted and then kept stable for 4 weeks. the dose will start at 25 milligrams of topiramate per day and will be increased 25 milligrams per day once weekly and then raised to either the target--100 milligrams per day--or the maximum dose that is well tolerated up to 200 milligrams per day. patients randomized to receive topiramate will remain on that dose. the comparison phase of the study is a 26-week period in which the change in migraine days of patients on topiramate (taking at least 50 milligrams per day) is compared with the change in migraine days for patients on the placebo. also studied will be the patients' health-related quality of life as assessed by questionnaires filled out at specific visits as well as the patients' views of the safety and tolerability of topiramate. the study hypothesis is that the number of migraine days, periods, and attacks during the last 4 weeks of the double-blind phase, relative to the last 4 weeks of the open-label phase, is reduced more in the topiramate group than the placebo group. during open-label (26-weeks) and double-blind phase (26-weeks), patients receiving topiramate will take 25 milligrams to 100 milligrams daily by mouth; increased by 25 milligrams per day once weekly; dose cannot exceed 200 milligrams per day and must be stable for the last 4 weeks.

Eligibility criteria:
inclusion criteria: * established history of migraine for at least one year; * migraine meets his (international headache society) criteria * an average of at least 4 monthly migraine days during the 3 months preceding trial entry * capable of keeping trial records; exclusion criteria: * patient used migraine prophylactic medication in the month prior to trial entry (flunarizine: 3 months prior to entry) * patient had failed (lack of efficacy) more than two adequate previous regimens of migraine prophylactic medications * patient had a history of severe drug allergy or hypersensitivity * patient overused analgesics, opiates, ergots and/or triptans * patient had been using topiramate regularly

Keywords: chronic migraine topiramate migraine headache chronic headache
behavioral and psychosocial characteristics of clients accessing services at ihri

Conditions: HIV

Summary: this protocol describes a 20-year prospective cohort study, gathering behavioral and psychosocial information on clients who access services of the institute of hiv research and innovation (ihri) and the thai red cross aids research centre through the thai red cross anonymous clinic, the thai red cross mobile clinics, affiliated health clinics, the gender and immunity clinic and pribta tangerine polyclinic. services provided through these sites include vct, std screening and treatment, anal and cervical pap smears, general health checkups, sexual health education, and sexual health communication, gender-affirmative hormone therapy (gaht) and risk-reduction via web boards and chat rooms. behavioral and psychosocial information will be collected using validated questionnaires and from data collection forms routinely used when providing services in different service sites of ihri and the trc-arc. the information will be collected anonymously at baseline and at follow-up visits, according to type of services each client receives. clients at the thai red cross anonymous clinic, thai red cross mobile health clinics, affiliated health clinics and pribta tangerine polyclinic will be given an identification number. qualitative methods, including focus group discussions (fgd) and in-depth interviews (idi) will be conducted with clients and healthcare providers to examine the facilitators, barriers, feasibility and acceptability of service implementation.

study objectives 1. to describe behavioral and psychosocial characteristics of clients who access services. 2. to understand the effectiveness of the hiv prevention package offered to clients who access services in terms of cost and infections averted 3. to study changes in behavioral and psychosocial characteristics among clients over time 4. to study differences in behavioral and psychosocial characteristics among clients by gender identity, sexual orientation, hiv status, and service sites 5. to assess behavioral and psychosocial factors that influence the willingness to participate in study trials 6. to assess the facilitators, barriers, feasibility and acceptability of and satisfaction with service implementation among clients and healthcare providers under ihri and trcarc

Eligibility criteria:
inclusion criteria: 1. 18 years or 16 and 17 years of age with parental or guardian consent in non- or pre-srs cases 2. recommendation1 by counsellor based on: a) presence of gd history b) understanding of risks and benefits of gaht d) practice and readiness for gender transition e) availability of social support f) ability to take hormones as instructed 3. verbal informed consent or signed informed consent on file 4. no exclusionary medical conditions 5. approved by physician in srs- and post-srs cases2 1. verbal informed consent or signed informed consent on file 2. no exclusionary medical conditions 3. approved by physician exclusion criteria: none
initial assessment of the effect of the addition of disulfiram (antabuse) to standard chemotherapy in lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: recent studies in laboratory animals demonstrate the ability of disulfiram to significantly inhibit the growth and metastasis of a mouse model of lung cancer. work with cells in vitro support the idea that this inhibition is mainly due to the inhibition of angiogenesis - the formation of new blood vessels in the tumor. furthermore, it was found out that the best effect has been obtained when disulfiram has been used not at the highest dose but at an optimal dose, which is smaller. thus, this trial will assess the addition of disulfiram to chemotherapy in non-small cell lung cancer (nsclca).

metastatic non small cell lung cancer remains a deadly disease with median survival times of several months. any treatment which can prolong patients' survival without causing severe side effects is of course an important addition to our limited arsenal in the fight against this disease. a recent article by marikowsky and colleagues extended significantly our knowledge regarding the possible activity of disulfiram (well known in its commercial name antabuse) as an anticancer agent (marikowsky et al int j of cancer 97 :34 2002). in this article it was demonstrated that disulfiram has potent antitumor activity and that it can act as a significant inhbitor of angiogenesis. since disulfiram has been well tolerated by thousands of patients, and there are observations that anti angiogenic therapy enhances the effect of chemotherapy (for example bevacizumab in combination with chemotherapy in colon carcinoma) we decided to conduct a clinical trial assessing the effect of the addition of this drug at moderate doses to chemotherapy which is used as one of the standard therapies in lung cancer. in order to obtain information regarding the effect of the addition of this drug, only 50% of the patients will be treated with the drug and the rest will be treated with placebo.

Eligibility criteria:
inclusion criteria: * metastatic non-small cell lung cancer * previously untreated * ecog performance status (ps) 0-1 * liver function tests within the norm exclusion criteria: * over 18 * willingness to abstain from alcohol * not pregnant * without a psychiatric history

Keywords: non-small cel lung cancer chemotherapy randomized phaseii disulfiram antiangiogenesis placebo
a phase 3 study to evaluate efficacy & safety of subcutaneous ct-p13 in patients with moderate to severe active rheumatoid arthritis

Conditions: Moderately to Severely Active Rheumatoid Arthritis

Summary: this is a randomized, placebo-controlled, double-blind, parallel-group, phase 3 study to evaluate the efficacy and safety of subcutaneous ct-p13 in patients with moderately to severely active rheumatoid arthritis


Eligibility criteria:
\[main inclusion criteria\] 1. patient who is male or female aged 18 to 75 years old (both inclusive). 2. patient who has a diagnosis of ra at least 24 weeks prior to the first administration of the study drug (day 1) and fulfill the 2010 acr/eular classification criteria for ra. 3. patient who has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed), 6 or more tender joints (of 68 assessed), and either a high-sensitivity c-reactive protein (hscrp) ≥1.0 mg/dl (≥10 mg/l) or an erythrocyte sedimentation rate (esr) ≥28 mm/hour at screening. 4. patient who has been receiving the treatment of oral or parenteral dosing with mtx for at least 12 weeks and has been on stable dosing with mtx between 10 to 25 mg/week for at least 4 weeks prior to the first administration of the study drug (day 1). 5. patient who has adequate renal and hepatic function at screening \[main exclusion criteria\] 1. patient who has previously received investigational or licensed product; biological agents or targeted synthetic disease-modifying antirheumatic drugs (dmards) (e.g., tofacitinib, baricitinib) for the treatment of ra and/or a tumor necrosis factor (tnf) α inhibitors for the any purpose. 2. patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product. 3. patient who has received or has plan to receive any of prohibited medications or treatments as defined in the protocol.
comparison of scalp microbiome of healthy women wearing hijab and those who do not wear hijab

Conditions: Microbial Colonization; Scalp--Diseases

Summary: an observational study was performed on 48 women wearing hijab and 48 women not wearing hijab to compare the scalp microbiome.

the scalp sample of all subjects was taken to be analyzed for its microbial diversity. the samples were processed with next-generation sequencer and analyzed with bioinformatics analysis. the primary outcome was the characteristics of scalp microbiome

Eligibility criteria:
inclusion criteria: * healthy women * aged 18 years old or older who had not undergone menopause * consenting to the study exclusion criteria: * scalp and hair diseases (e.g. alopecia, trichotillomania, scalp infection, malignancy) * systemic diseases (diabetes mellitus, liver diseases, renal diseases, autoimmune diseases) * use of topical and oral antifungal agents * use of cytostatic agents * use of topical and oral antibiotics * use of topical and oral vitamin d * use of chemical products on hair (e.g. bleaching, permanent blow, hair coloring, hair straightener) * pregnancy * lactating * hypersensitivity towards basic ingredients of shampoo (e.g. synthetic detergent, conditioner, thickening agent).

Keywords: scalp microbiome hijab
integrated pet/mri and germline variants to differentiate brain tumopr recurrence from iatrogenicchanges in children

Conditions: Pediatric Brain Tumor

Summary: nuclear magnetic resonance imaging (nmr) is used in pediatric brain tumors for purposes of diagnosis, evaluation of response to treatments, and monitoring of patients in follow-up. through conventional imaging techniques it remains difficult to differentiate tumor recurrence from pseudo-progression or other iatrogenic changes after radiotherapy or chemotherapy, but it remains a relevant and essential clinical need for patient management.


Eligibility criteria:
inclusion criteria: * children and/or adolescents (≤18 years) diagnosed with brain tumor. * children who underwent the contemporary adjuvant therapy protocol of post-surgical chemo and radiotherapy. exclusion criteria: * patients \>18 years